Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

— Cardiocare  

Official title:

Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480087
• Other study ID #: Cardiocare
• Status: Completed
• Start date: January 2015
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age >18 years

• Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)

• Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)

• Written informed consent

Exclusion Criteria:

• Age > 70 years

• Unable to perform anthracyline containing regimen

• Previous treatment with mediastinal radiotherapy

• Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)

• ECOG PS > 2

• Echocardiographic acoustic windows not suitable for strain evaluation

• Any other conditions or situations preventing patients to sign informed consent

Related Conditions & MeSH terms

• Cardiotoxicity
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Toxicity, Cardiac

Locations

Country	Name	City	State
Italy	SC Ematologia - AOU Città della salute e della Scienza di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	Left ventricular ejection fraction measured by echocardiography	Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)
Primary	Global Longitudinal Strain (GLS)	Global Longitudinal Strain measured by strain-rate echocardiography	Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion)
Secondary	Anthracycline cumulative dose	Anthracycline cumulative dose	4/6 month after baseline (end of chemotherapy)
Secondary	T troponin	T troponin rate	Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion)